Find information on thousands of medical conditions and prescription drugs.

Fortamet

Metformin (Glucophage®, Fortamet®, Riomet®) is an anti-diabetic drug from the biguanide class (its other members are the withdrawn agents phenformin and buformin). more...

Home

Femara

Femring

Filipin

Flagyl

Flarex

Flavoxate

Flecainide

Flexeril

Flomax

Flonase

Flovent

FML

Focalin

Fosamax

Frova

Fuzeon

Uses

The main use for metformin is for the treatment of diabetes mellitus, especially when it is concomitant with obesity and insulin resistance.

It is also being used increasingly in polycystic ovary syndrome (PCOS) and non-alcoholic steatohepatitis, two other diseases that feature insulin resistance; these indications are still considered experimental.

Metformin is the only anti-diabetic drug that has been proven to reduce the complications of diabetes, as evidenced in a large study of overweight patients with diabetes (UKPDS 1998).

Metformin is often prescribed to type 2 diabetes patients in combination with rosiglitazone maleate. This drug actively reduces insulin resistance, complementing the action of the metformin. In 2002, the two drugs were combined into a single product, Avandamet, marketed by GlaxoSmithKline. . In 2005, all current stock of Avandamet was seized by the FDA and removed from the market. This was due to problems at the manufacturing plants, not to any medical issues resulting from the drugs use. The drug pair continued to be prescribed separately in the absence of Avandamet itself, which was readily available by the end of that year.

Mechanism of action

Despite its therapeutic benefits, the mechanism of action of metformin is uncertain. Its mode of action appears to be reduction of hepatic gluconeogenesis; the "average" person with type 2 diabetes has three times the normal rate of gluconeogenesis. Metformin treatment reduces this by one third to two thirds. It is has been shown that metformin also decreases intestinal absorption of glucose. A third mechanism is that metformin improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Zhou et al (2001) showed that metformin stimulates the hepatic enzyme AMP-activated protein kinase.

Side-effects

The most serious side effect of metformin is lactic acidosis. However, this complication is rare if the contra-indications are followed, as it seems limited to those with impaired liver and/or kidney function.

Phenformin was withdrawn because of an increased risk of lactic acidosis (up to 60 cases per million patient-years). In recent studies it was revealed that, as long as it is not prescribed to patients who are at risk, metformin is much safer, and the risk of lactic acidosis approximates that of people who are not on the medication (Salpeter SR et al 2003).

The most common side effect of metformin is gastrointestinal upset. This includes diarrhea, cramps, nausea and vomiting. In a clinical trial of 286 subjects, 53.2% of the 141 who were given Metformin IR (as opposed to placebo) reported diarrhea, and 25.5% reported nausea/vomiting (source: Drug Facts & Comparisons 2005).

Read more at Wikipedia.org

• [List your site here Free!]

Andrx Receives FDA Approval of Fortamet; Also Plans to Market Altocor Under A New Name
From Business Wire, 4/28/04

Business Editors/Health/Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--April 28, 2004

Andrx Corporation (Nasdaq:ADRX) ("Andrx") today announced that the United States Food and Drug Administration ("FDA") has granted final marketing approval of Andrx's New Drug Application (NDA) for Fortamet(TM) (metformin HCl) Extended-Release Tablets, 500 mg and 1000 mg. This NDA provides for the use of Fortamet as an adjunct to diet and exercise in order to lower blood glucose in patients with type 2 diabetes. Andrx is planning to launch Fortamet in May 2004.

Thomas P. Rice, Andrx's Chief Executive Officer, said: "Our 500 mg and 1000 mg strengths of once-a-day Fortamet offer improved convenience and a reduction of pill burden for patients. Our 500 mg tablet is smaller than other currently available metformin tablets, and our 1000 mg tablet is a unique strength that will allow patients to more easily manage their optimal daily dosage requirements. These two strengths of Fortamet are intended to improve patient compliance and further demonstrate the value of Andrx's controlled-release technologies."

Fortamet extended-release tablets employ Andrx's patented single-composition osmotic technology (SCOT(TM)). Fortamet is an extended-release metformin that suppresses hepatic glucose production and improves peripheral insulin sensitivity.

More than 17 million people in the United States have diabetes mellitus, where the most common is type 2 diabetes. Approximately 90% of those diagnosed with diabetes are treated for type 2 diabetes and, over the last decade, the prevalence of type 2 diabetes has increased significantly in all age groups. Type 2 diabetes is a condition characterized by high blood glucose levels caused by either a lack of insulin or the body's inability to use insulin effectively.

The Company also announced today that, in order to avoid possible confusion in the marketplace, it is in discussions with the FDA to market its Altocor product under a new name. These discussions include, but are not limited to, the timing of this name change and the labeling of the product.

About Andrx Corporation

Andrx Corporation is a pharmaceutical company that: develops and commercializes generic versions of controlled-release brand name pharmaceuticals, using the Company's proprietary controlled-release drug delivery technologies, and generic versions of niche and immediate-release pharmaceutical products, including oral contraceptives; distributes pharmaceuticals, primarily generics, manufactured by others as well as manufactured by the Company, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices; and commercializes brand pharmaceuticals, in some instances using the Company's proprietary controlled-release drug delivery technologies.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, Andrx's dependence on a relatively small number of products; licensing revenues; the timing and outcome of patent, antitrust and other litigation; the timing and commercial success of future generic and brand product approvals and launches, including Fortamet; the timing and effects of the change of the Altocor name; whether Andrx will be awarded any market exclusivity period and, if so, the precise dates thereof; government regulation generally; competition; manufacturing capacities, output and quality processes; Andrx's ability to develop and successfully commercialize new products; the loss of revenues from existing products; development and marketing expenses that may not result in commercially successful products; Andrx's inability to obtain, or the high cost of obtaining, licenses for third party technologies; commercial obstacles to the successful introduction of brand products generally, including Fortamet and Cardura XL; the success of Andrx's joint ventures; the impact of returns, allowances and chargebacks; product liability claims; and the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals. Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission. Andrx disclaims any responsibility to update the statements contained herein.

This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com.

Return to Fortamet

Home

Contact

Resources

Exchange Links

ebay